510(k) Report

FDA applicant

Tanabe U.S.A., Inc.

San Diego, CA8 decisions1993–19940 recalls

FDA records 8 decisions for Tanabe U.S.A., Inc. (San Diego, CA) from 1993 to 1994: 8 510(k) clearances. All are in product code JIL (Method, Enzymatic, Glucose (Urinary…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Tanabe U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tanabe U.S.A., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tanabe U.S.A., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)8decisions

What has FDA decided for it lately?

  • K932368Uropaper Eiken 6BTanabe U.S.A., Inc. · 1994
  • K932366Uropaper Eiken HagTanabe U.S.A., Inc. · 1993
  • K932365Uropaper Eiken AGTanabe U.S.A., Inc. · 1993
  • K932363Uropaper Eiken GKTanabe U.S.A., Inc. · 1993
  • K932369Uropaper Eiken 7Tanabe U.S.A., Inc. · 1993
  • K932367Uropaper Eiken 8Tanabe U.S.A., Inc. · 1993
  • K931897UropaperTanabe U.S.A., Inc. · 1993
  • K932364Uropaper Eiken GPTanabe U.S.A., Inc. · 1993

All 8 as Tanabe U.S.A., Inc. →